CD19 Sequential CD22 In Vivo CAR-T Cell Immunotherapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
NCT07927816, Phase 1, Recruiting, Liping Dou
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | CD19 Sequential CD22 In Vivo CAR-T Cell Immunotherapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia | ClinicalTrials.gov |
| NCT number | NCT07927816 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 12 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Liping Dou | ClinicalTrials.gov |
| Conditions | Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia, In Vivo CAR-T, B-Cell Acute Lymphoblastic Leukemia | ClinicalTrials.gov |
| Interventions | CD19-Targeted In Vivo CAR-T Injection (first infusion, Day 0); CD22 -Targeted In Vivo CAR-T Injection (second infusion, Day 7) | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Safety and Tolerability | From the first in vivo CAR-T infusion through 12 months after treatment | DLTs, the number and percentage of participants who experience DLT during the protocol-defined DLT observation period (Days 0-28) after the first in vivo CAR-T infusion. | ClinicalTrials.gov |
| Primary | Adverse Events | From the first in vivo CAR-T infusion through 12 months after treatment | AEs are graded per NCI CTCAE v5.0 | ClinicalTrials.gov |
| Primary | Cytokine Release Syndrome | From the first in vivo CAR-T infusion through 12 months after treatment | Cytokine release syndrome (CRS) is graded according to the ASTCT consensus criteria. | ClinicalTrials.gov |
| Primary | Immune Effector Cell-associated Neurotoxicity Syndrome | From the first in vivo CAR-T infusion through 12 months after treatment | immune effector cell-associated neurotoxicity syndrome (ICANS) is graded according to the ASTCT consensus criteria. | ClinicalTrials.gov |
| Secondary | Objective Response Rate at Prespecified Follow-up Time Points | From the first in vivo CAR-T infusion through 24 months after treatment | The objective response rate (ORR) at 1, 2, 3, 6, 9, 12, 18, and 24 months after treatment, defined as the proportion of participants who achieve a complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or complete remission with incomplete platelet recovery (CRp). The ORR at 3 months after treatment is the key evaluation time point. | ClinicalTrials.gov |
| Secondary | Overall Survival | From the first in vivo CAR-T infusion through 24 months after treatment | Overall survival (OS), defined as the time from the first in vivo CAR-T infusion to death from any cause. Participants who are alive at the last follow-up will be censored on the date of their last known survival status. | ClinicalTrials.gov |
| Secondary | Progression-Free Survival | From the first in vivo CAR-T infusion through 24 months after treatment | Progression-free survival (PFS), defined as the time from the first in vivo CAR-T infusion to the first documentation of objective disease progression or death from any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Event-Free Survival | From the first in vivo CAR-T infusion through 24 months after treatment | Event-free survival (EFS), defined as the time from the first in vivo CAR-T infusion to the first documentation of objective disease progression, relapse, or death from any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Measurable Residual Disease (MRD) Negativity Rate | At Day 28 and Months 2, 3, 6, 9, 12, 18, and 24 after the first in vivo CAR-T infusion | The proportion of participants with MRD negativity in bone marrow assessed by multiparameter flow cytometry among participants who achieve CR/CRi, at each prespecified assessment time point. | ClinicalTrials.gov |
| Secondary | Cellular Kinetics (Pharmacokinetics) of In Vivo-Generated CAR-T Cells (Exploratory) | Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion | CAR transgene copy number in peripheral blood (qPCR), peak expansion of CAR-T cells in peripheral blood (Cmax). | ClinicalTrials.gov |
| Secondary | Time to Peak Expansion | Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion | Peripheral blood sampling is planned on Days 2, 4, 6, 8, 10, 12, 14, 17, 21, 24, and 28 and at Months 2, 3, 6, 9, and 12 after infusion. | ClinicalTrials.gov |
| Secondary | Area Under The Curve From Day 0 to Day 28 | Through Day 28 for AUC0-28d, Cmax, and Tmax; CAR transgene levels through 12 months after infusion | The area under the curve from Day 0 to Day 28 (AUC0-28d).Peripheral blood sampling is planned on Days 2, 4, 6, 8, 10, 12, 14, 17, 21, 24, and 28 and at Months 2, 3, 6, 9, and 12 after infusion. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)